Certified Pharmaceutical GMP Professional : 6 Practice Tests
Pass Certified Pharmaceutical GMP Professional exam with Confidence: 6 Practice Tests with Explanations (Unofficial)
Certified Pharmaceutical GMP Professional : 6 Practice Tests free download
Pass Certified Pharmaceutical GMP Professional exam with Confidence: 6 Practice Tests with Explanations (Unofficial)
“Certified Pharmaceutical GMP Professional: 6 Practice Exams” is a rigorously designed self-study program that prepares you to pass the ASQ-CPGP exam—and, more importantly, to operate confidently in any Good Manufacturing Practice (GMP) environment. The course combines six timed, scenario-rich practice exams with concise refreshers on every body-of-knowledge domain, giving you an end-to-end rehearsal of the real certification experience.
Whether you work in QA/QC, production, validation, regulatory affairs, or R&D, you will strengthen the practical skills that drive inspection readiness, product quality, and global compliance. Each practice exam mirrors the style, proportional weighting, and difficulty of the official test, while detailed answer rationales tie every question back to current regulations and industry best practices.
What the Course Covers
I. GMP Regulations and Guidelines (23 %)
History and evolution of GMP frameworks (FDA, EU-GMP, WHO-GMP, PIC/S, ICH)
21 CFR Parts 210 & 211; EU EudraLex Vol 4; WHO GMP Annexes
ICH Q7 - Q11; PIC/S guide updates
FDA 483s and warning-letter trends
Cross-comparison of US, EU, WHO, and Indian GMP requirements
II. GMP Principles and Applications (23 %)
Good documentation practices, change control, and CAPA systems
Validation types (prospective, concurrent, retrospective)
Equipment qualification (DQ, IQ, OQ, PQ)
Root-cause analysis tools and risk management per ICH Q9
Data-integrity expectations: ALCOA+, audit trails, 21 CFR Part 11
III. Laboratory Systems and Equipment (14 %)
Analytical-method validation strategy
Calibration, maintenance, and qualification of instruments
Environmental monitoring, water systems, and HVAC controls
Managing OOS investigations and microbiological quality
Raw-data integrity and traceability in QC labs
IV. Quality Systems and Compliance (20 %)
Pharmaceutical Quality System (ICH Q10) architecture
Internal audits, supplier qualification, and deviation investigations
Product lifecycle management, change management, and QA batch release
Workforce training, competency mapping, and continuous improvement
V. Product Development and Technology Transfer (10 %)
GMP expectations across R&D, scale-up, and pilot stages
Design of Experiments (DoE) for robust formulations
Technology-transfer protocols, documentation, and comparability studies
Facility/equipment readiness and knowledge capture
VI. Manufacturing and Packaging (10 %)
Process control for sterile and non-sterile operations
Packaging-line balancing, reconciliation, and serialization
In-process controls (IPCs) and real-time decision making
Batch manufacturing and packaging records (MBRs/BPRs)
GMP warehousing and material-management principles
VII. Investigations and Enforcement (Integrated in MCQs)
Responding to FDA 483s and warning letters
Inspection preparation, conduct, and mock-audit programs
Enforcement actions, remediation planning, and post-inspection follow-up
How the Practice Exams Work
Six full-length exams (multiple-choice, scenario-based) reflecting official topic weightings.
Timed test interface for realistic pacing and stress management.
Detailed explanations and reference links for every answer, turning each attempt into a mini-lesson.
Performance analytics to track scores by knowledge area and prioritize weak spots.
Key Outcomes
By the end of this course you will be able to:
Interpret and apply US, EU, WHO, and PIC/S GMP requirements with confidence.
Design, implement, and audit effective quality-management and validation systems.
Investigate deviations, OOS results, and data-integrity issues using structured root-cause tools.
Prepare for—and excel during—regulatory inspections and third-party audits.
Walk into the ASQ-CPGP exam knowing what to expect and how to manage your time.
